(134 days)
Not Found
No
The description focuses on mechanical features and fluid delivery, with no mention of AI or ML.
No
The device is used to administer fluids, not to provide therapy itself. It is a tool for delivery rather than a therapeutic agent.
No
The device is described as an "Intravascular Administration Set" used for "administration of fluids" to a patient's vascular system. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical components such as a needle, catheter, flow regulator, drip chamber, tubing, connectors, and a hollow spike, indicating it is a hardware device. The performance studies also focus on physical properties like pull, pressure, joint strength, and drop testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is an Intravascular Administration Set. Its function is to deliver fluids into the patient's vascular system. This is a direct interaction with the patient's body, not the testing of a specimen.
- Intended Use: The intended use clearly states it provides access for the administration of fluids to the patient's vascular system.
Therefore, based on the provided information, this device is a medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3 in 1 IV Administration Set is used to administer fluids front a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.
The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pull testing, pressure testing, joint strength testing, and drop testing has been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
AUG 23 2005
510(k) Summary VitalCare Group, Inc. 8935 NW 27th Street Miami. FL 33172 Tel 305-620-4007 Fax 305-620-9989 Contact: Ramzi Abulhaj, President Date: August 15, 2005
Device: "3 In 1" I V Administration Set I.
| Common Name: | I. V. Administration Set |
|---|---|
| Classification Name: | Set, Administration, Intravascular |
| Panel: | General Hospital and Personal Use |
| Product Code: | FPA |
| Device Classification: | II |
DEVICE DESCRIPTION II.
The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.
INTENDED USE OF THE DEVICE III.
The 3 in 1 IV Administration Set is used to administer fluids front a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.
1
KD50906
2
Comparison Table
| Feature | Detail | Predicate
K925465 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | The VitalCare 3 in 1 IV Administration Set is used to
administer fluids from a container to a patient's vascular
system through a needle or catheter inserted into the vein.
The device may include the tubing, a flow regulator, drip
chamber, Y port, needleless injection port, backflow valve,
fluid delivery tubing, connectors between parts of the set and
a hollow spike to connect the tubing to an IV bag or
medication bag. | Identical |
| Components | Spike, ABS, Polylac PA-747
Spike Cover, PE
Luer Locks, Male and Female, ABS, Polylac PA-747
Luer Protective Covers, Polypropylene R701G
PVC Tubing, Medical Grade DEHP free, 2228GBF-65S
Clear
Y Port/Split Septum, ABS, Polylac PA-747
Needleless Y Port, ABS, Polylac PA-747
Extension Tube, Medical Grade DEHP free PVC/ABS
3 in 1 Flow Regulator, ABS, Polylac PA-747
Back Flow Valve, ABS, Polylac PA-747
Roller Clamp, ABS, Polylac PA-747
Tube Clamp, ABS, Polylac PA-747
Pouch, Polypropylene R701G
Kraft triple wall Corrugated fiberboard | Similar
components and
materials |
| Performance
Tests | Biocompatibility
Bench Testing
Sterilization/Residuals | Similar |
| Labeling | Reorder Number
Size
Quantity
Lot Number
Sterile
Bar Code
DEHP Free
Latex Free
Single Use Only
Pouch and Shipping case
Manufacturer Address | Similar |
| Packaging | 50 pouches per case | Similar |
| Sterilization | Sterile (EO) | Sterile (EO) |
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page 3 of 3
510(k) Summary VitalCare Group, Inc.
IV Performance Data
Pull testing, pressure testing, joint strength testing, and drop testing has been performed.
V. Conclusion
The VitalCare "3 in 1" IV Administration Set is substantially equivalent to the above products by having the identical indication for use and similar materials used for construction.
The materials used to manufacture the VitalCare IV Administration Set are used in legally marketed devices under comparable conditions.
Comparison of the predicate device to the VitalCare IV Administration Set for technological differences showed no significant difference.
VI. Description of the Marketed Equivalent Device:
| Common Name: | IV Administration Set |
|---|---|
| Classification Name: | Set, Administration, Intravascular |
| Product Code: | FPA |
| Applicant: | Biomedix Inc. |
| 23 South Main Street | |
| P. O. Box 231 | |
| Spencer, IN 47460 | |
| Equivalent Device | K925465, IV Set |
Intended Use of the Marketed Equivalent Device: VII
The Selec-3 is an adjustable 3 in 1 volume IV Set is used to administer fluids from a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, an infusion line filter, backflow valve an IV set stopcock, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines forming the body and head, and two curved lines representing the legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2005
VitalCare Group, Incorporated C/O Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K050906
Trade/Device Name: VitalCare I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 7, 2005 Received: July 7, 2005
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
4
Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Huang
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_VitalCare I. V. Administration Set
Indications For Use: The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.
Prescription Use V
AND/OR
Over-The-Counter Use
. . . . . . . . . . . . . . . . . . . . . . . . .
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintur ve, me
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:___________________________________________________________________